TRAIL Study: Feasibility and Pilot

Launched by DARTMOUTH-HITCHCOCK MEDICAL CENTER · Jan 14, 2024

Keywords

ClinConnect Summary

The TRAIL Study is a pilot clinical trial designed to explore two different approaches for managing thyroid nodules that might be cancerous. Currently, when doctors find these nodules through ultrasound, the usual practice is to perform an immediate biopsy (a tissue sample). This study will compare this usual care approach with a method called active monitoring, where patients would have regular ultrasound checks and close follow-up with their doctor instead of an immediate biopsy. The main goals are to see how each method affects patients' anxiety levels and their overall quality of life related to their thyroid health after six months.

To participate in this study, individuals must be at least 18 years old and meet certain criteria. They should not have any symptoms from the nodule, and the nodule must be no larger than 2 centimeters and rated as suspicious (TI-RADS 4 or 5) on an ultrasound. People who have had certain types of thyroid cancer or previous treatments that might complicate their condition may not be eligible. Participants will be randomly assigned to one of the two treatment groups and will be asked to share their experiences, which may be recorded for research purposes. This study is not yet recruiting participants, but it aims to help improve the understanding of how to best manage thyroid nodules in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Participants must be ≥18 years of age.
• • Participants must be able and willing to provide informed consent or have a surrogate capable of providing same.
• • Participants must be absent of symptoms referable to the nodule: dysphagia or nodule physically visible and/or bothersome to patient.
• • Participants' thyroid nodule must have a TI-RADS rating of 4 or 5.
• • Participants thyroid nodule must be ≤2 cm in largest diameter.
• • Participants must be being considered for biopsy.
• • Participants with a prior history of papillary thyroid cancer are eligible.
• Exclusion Criteria:
• Patients who fall into one of the following categories will NOT be eligible for this study:
• • Adults who are unable to provide informed consent.
• • Patients for whom biopsy is not a consideration.
• • Patients with a prior history of thyroid cancer other than papillary thyroid cancer.
• • Patients with a history of radiation to the neck.
• • Patients who are athyroidal (thyroid gland has been removed or patient has only lingual thyroid tissue).
• * Patients who have ultrasound evidence of one or more of the following:
• • Airway invasion of the nodule.
• • Nodule adjacency to/invading the recurrent nerve.
• • Extra-thyroidal invasion by the nodule.
• • Patients who have metastasis to cervical lymph nodes (confirmed by needle biopsy if ultrasound suspicious), distant metastases, if identified) testing not required, not usual care)
• • Patients who have already had a biopsy of the nodule being considered for inclusion in the study.
• • TRAIL Pilot Integrated QRI: Inclusion/Exclusion Criteria
• Inclusion Criteria for Study Patient Participants:
• • Participants must meet the eligibility requirements above and will be or have been approached about enrolling in the pilot study.
• • Participants must be willing to allow audio recorder presence and / or willing to be interviewed by the QRI team.
• Exclusion Criteria for Study Patient Participants:
• • -Patients who are not willing to allow audio recorder presence and/or not willing to be interviewed by QRI team will be excluded from this study.
• Inclusion Criteria for Study Staff Participants:
• • Staff must be willing to audio record their communications with patients about enrolling in the study.
• • Staff must be willing to participate in interviews with QRI team about their views of the study.
• Exclusion Criteria for Study Staff Participants:
• • -Staff members who are not willing to participate in audio taping of recruitment discussions and/or interviews with QRI team about their views of the study will be excluded.